AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking

NCT06511713 | Recruiting

• 1 other identifier: SHDC2022CRD026
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop models for the classification and early warning of common mental disorders. These models will assist clinicians in making objective diagnoses of common mental disorders and in predicting the risk of adverse outcomes, thereby addressing the significant technical bottleneck of the current lack of objective diagnostic and warning instruments for mental disorders.

Conditions

Mental Disorder

Keywords

eye movement

Outcome Measures

Primary Outcomes (2)

• Eye-tracking fixation point trajectory

  Eye-tracking fixation point trajectory during free viewing of specific images by the participant (5 minutes)

  1 year

• Fundus examination

  Color fundus imaging collected by a digital fundus camera (Canon CR-2) under non-mydriatic conditions of the participant

  1 year

Study Arms (2)

the Clinical High Risk for Psychosis (CHR) Group

Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfill at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome

Other: routine clinical treatment

the Clinically Diagnosed Common Mental Disorders Group

1,000 patients with common mental disorders, including 300 patients with schizophrenia, 300 patients with affective disorders, 200 patients with anxiety disorders, and 200 patients with cognitive impairment in the elderly.

Other: routine clinical treatment

Interventions

routine clinical treatment OTHER

Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.

the Clinical High Risk for Psychosis (CHR) Group; the Clinically Diagnosed Common Mental Disorders Group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Help-seeking first-visit participants will be consecutively recruited from the Shanghai Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre. They will be screened for eligibility by their clinicians.

You may qualify if:

• be aged 14 to 45-year-old
• have had at least 6-years of primary education
• be drug-naïve
• be understanding the survey, be willing to enrol in the study and sign the informed consent
• Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome
• Meets ICD-11 diagnostic criteria for schizophrenia
• Meets ICD-11 diagnostic criteria for mood disorders
• Meets ICD-11 diagnostic criteria for anxiety disorders
• Meets ICD-11 diagnostic criteria for neurocognitive disorders

You may not qualify if:

• Acute or chronic renal failure; liver cirrhosis or active liver diseases
• Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects
• Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L
• Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial
• Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial
• Stroke within the last month
• Participating in any clinical trial within 30 days before the baseline
• Other situations judged by the investigators not to be suitable for the clinical trial

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

• TianHong Zhang, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TianHong Zhang, Doctor

CONTACT

13127577024; zhang_tianhong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: July 20, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)